Crohn Clinical Trial
Official title:
Study of Photographs of Interest in Training to Obtain Good Reproducibility of the Diagnosis of Perianal Lesions of Crohn's Disease Inspection in Internal Gastroenterology
The diagnosis of LAP (lesions Ano-perineal) requires the inspection, palpation, anoscopy and
possibly additional examinations including endoscopy and imaging; any of these steps of the
diagnosis can only be replaced by another.
In the absence of data in the literature on the evaluation of specific LAP Crohn inspection,
Clemence Horaist et al established definitions of these lesions inspection with the help of
an expert group, then evaluated the diagnostic agreement LAP these definitions in the same
group from a selection of photographs. Definitions ulceration, fistula, inflammatory external
os, erythema and abscess had an acceptable agreement diagnosis (kappa> 0.70)
The LAP is a predictor of severe Crohn's disease, hepato any gastroenterologist it is
appropriate that recognizes and adopts adequate care, this care has been a consensus in 2014.
The interns Hepato gastroenterology must learn during their training to know the terminology
of LAP Crohn inspection and to recognize so considered acceptable by experts.
Study Objectives:
In this context, the investigators work is to show that training giving the consensus
definitions of Crohn's lesions on inspection and typical images of these lesions is effective
to enable students to achieve a level of diagnosis of these lesions acceptable to experts
(ideally not significantly different from that of the experts). Assuming alternates, we will
identify difficult diagnosis of lesions for students to find the most appropriate teaching
method
Inclusion criteria: all Gastroenterology Hepato-house of France (including overseas
territories)
Methodology:
non-interventional multicentre prospective study
February 2015 to July 2015
Statistical analysis: Clinical Research Centre of the coordinating center. Quantitative
variables are expressed by their mean, standard deviations, their minimum and maximum values
as appropriate. The variables will be expressed in numbers and percentages.
Development of the study:
- A broad group of experts (19 proctology and a dermatologist) will be contacted to choose
two typical images of LAP (superficial ulceration, deep ulceration ...) from a selection
of photos and give their opinions about fistula definition proposal. (Photos used does
not identify patients, they have just typical lesions of LAP)
Typical pictures chosen by the experts will be integrated into the training material issued
after 1 internal questionnaire. This support will appear on one page and resume the
definitions established by experts with or without the typical pictures.
- Internal Gastroenterology France (about 470 domestic total) will be contacted by email,
their department heads have been told that work.
- Internal will inform their characteristics:
- Internal details: name, email address
- Year boarding.
- boarding area.
- Validation IUD (inter-university degree) 1st / 2nd year of proctology.
- Conducting an internal internship in a proctology service?
- Participation in specific courses on the LAP?
- buddy Training on LAP?
- Sending a first questionnaire to internal Google Drive: description pictures of LAP (12
photos lesion initially selected by experts) using checkboxes. Eg ulceration: YES / NO /
DO NOT KNOW (Figure 1). The Google Drive platform enables automatic input results in a
Microsoft Excel database.
- Draw (using a randomization list EXCEL based on the random function of EXCEL) of 2
groups:
- Group A (training with typical definitions established + photos)
- Group B (only definitions)
- Sending mail to the board of education, different depending on the group, the internal
will have as long as they wish
- Sending a second questionnaire with pictures of different LAP those of the first
questionnaire. Answers by checkboxes.
- Analysis: a schedule will each questionnaire with a weighting based on the primary /
secondary diagnosis. A comparison of pre and post training scores will be performed. And
this difference may be calculated between the two groups A and B. In addition, the
difficult diagnosis of lesions will be identified.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01440699 -
Study of Allogenic Adipose-derived Stem Cells in Crohn's Fistula
|
Phase 1 |